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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04192097
Other study ID # CESAR003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2019
Est. completion date March 1, 2021

Study information

Verified date November 2023
Source University Grenoble Alps
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of a curriculum about professionalism on stress response during a critical situation in anesthesiology residents. Residents in anesthesiology will complete a training program on professionalism during their first postgraduate year. They will go through a standardized simulated scenario where they have to manage an intra-hospital cardiorespiratory arrest and then meet the patient's family. Stress response will be assessed and compared to a control group that did not receive the training program.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 1, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Residents in anesthesiology (Postgraduate year 1) - Voluntary Exclusion Criteria: - /

Study Design


Intervention

Other:
Professionalism curriculum
One year training program including ten two-hours sessions about Knowing yourself Interaction with patients and their families Teamwork and organization with colleagues

Locations

Country Name City State
France University hospital Grenoble Alps La Tronche

Sponsors (1)

Lead Sponsor Collaborator
University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological stress response : State Trait Anxiety Inventory (STAI) STAI -State (State-Trait Anxiety Inventory), from 20 to 80, psychological stress response is higher when score is higher 1 year
Secondary Clinical performance on cardiopulmonary arrest All simulations will be videotaped and the clinical performance of each participant will be assessed by an independent evaluator using a specific pre-established checklist 1 year
Secondary Physiological stress response : Standard Deviation Heart rate variability evaluated by Standard Deviation Normal to Normal, in milliseconds. Physiological stress response is higher when Standard Deviation Normal to Normal, is lower. 1 year
Secondary Family meeting quality : Gather-Resources-Identify-Educate-Verify-Inquire-"Nuts and bolts"-Give All simulations will be videotaped and the family meeting quality will be assessed by an independent. Score GRIEV-ING from 0 to 27 evaluator, using the Gather, Resources, Identify, Educate, Verify, Inquire, Nuts and bolts, Give), from 0 to 27, family meeting is better when score is higher 1 year
Secondary Non technical skills (NTS) : Crisis resource management ( CRM). Score Ottawa Score Ottawa from 5 to 35 1 year
Secondary Burnout Scale Maslach Burnout Inventory, from 0 to 132 points, exploring three dimensions of professional burnout 1 year
Secondary Quality Of Life : WHOQoL WHOQoL-8 (World Health Organization Quality of Life), from 12 to 60 points, quality of life is higher when the score is lower 1 year
Secondary Psychological stress response Stress Visual Analogical Scale, from 0 to 100, psychological stress response is higher when score is higher 1 year
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